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  1. DESCRIPTION
  2. CLINICAL PHARMACOLOGY
  3. INDICATIONS AND USAGE
  4. CONTRAINDICATIONS
  5. WARNINGS
  6. PRECAUTIONS
  7. ADVERSE REACTIONS
  8. DRUG ABUSE AND DEPENDENCE
  9. OVERDOSAGE
  10. DOSAGE AND ADMINISTRATION
  11. HOW SUPPLIED



Butalbital 50 MG / aspirin 325 MG / caffeine 40 MG Oral Capsule uses

DESCRIPTION

Each Butalbital 50 MG / aspirin 325 MG / caffeine 40 MG Oral Capsule, aspirin, and caffeine capsule for oral administration contains: butalbital 50 MG / aspirin 325 MG / caffeine 40 MG Oral Capsule, USP, 50 mg; aspirin, USP, 325 mg; caffeine, USP, 40 mg.
butalbital 50 MG / aspirin 325 MG / caffeine 40 MG Oral Capsule (5-allyl-5-isobutylbarbituric acid) is a short- to intermediate-acting barbiturate. It has the following structural formula:
Aspirin (benzoic acid, 2-(acetyloxy)-) is an analgesic, antipyretic, and anti-inflammatory. It has the following structural formula:
Caffeine (1, 3, 7-trimethylxanthine) is a central nervous system stimulant. It has the following structural formula:
Active Ingredients: aspirin, USP, butalbital 50 MG / aspirin 325 MG / caffeine 40 MG Oral Capsule, USP, and caffeine, USP.
Inactive Ingredients: pregelatinized starch, microcrystalline cellulose, sodium starch glyco­late, trimyristin, talc, colloidal silicon dioxide, D&C Yellow No. 10, FD&C Green No. 3, and gelatin. The capsule imprinting ink contains: shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, ethanol, methanol, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, and D&C Yellow No. 10 Aluminum Lake.
butalbital-molec-structure aspirin-molec-structure caffeine-molec-structure
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CLINICAL PHARMACOLOGY

Pharmacologically, butalbital 50 MG / aspirin 325 MG / caffeine 40 MG Oral Capsule, aspirin, and caffeine capsules combine the analgesic properties of aspirin with the anxiolytic and muscle relaxant properties of butalbital 50 MG / aspirin 325 MG / caffeine 40 MG Oral Capsule.
The clinical effectiveness of butalbital 50 MG / aspirin 325 MG / caffeine 40 MG Oral Capsule, aspirin, and caffeine capsules in tension headache has been established in double-blind, placebo-controlled, multi-clinic trials. A factorial design study compared butalbital 50 MG / aspirin 325 MG / caffeine 40 MG Oral Capsule, aspirin, and caffeine capsules with each of its major components. This study demonstrated that each component contributes to the efficacy of butalbital 50 MG / aspirin 325 MG / caffeine 40 MG Oral Capsule, aspirin, and caffeine capsules in the treatment of the target symptoms of tension headache. For each symptom and the symptom complex as a whole, butalbital 50 MG / aspirin 325 MG / caffeine 40 MG Oral Capsule, aspirin, and caffeine capsules were shown to have significantly superior clinical effects to either component alone.

Pharmacokinetics

The behavior of the individual components is described below.
Aspirin
The systemic availability of aspirin after an oral dose is highly dependent on the dosage form, the presence of food, the gastric emptying time, gastric pH, antacids, buffering agents, and particle size. These factors affect not necessarily the extent of absorption of total salicylates but more the stability of aspirin prior to absorption.
During the absorption process and after absorption, aspirin is mainly hydrolyzed to salicylic acid and distributed to all body tissues and fluids, including fetal tissues, breast milk, and the central nervous system (CNS). Highest concentrations are found in plasma, liver, renal cortex, heart, and lung. In plasma, about 50% to 80% of the salicylic acid and its metabolites are loosely bound to plasma proteins.
The clearance of total salicylates is subject to saturable kinetics; however, first-order elimination kinetics are still a good approximation for doses up to 650 mg. The plasma half-life for aspirin is about 12 minutes and for salicylic acid and/or total salicylates is about 3.0 hours.
The elimination of therapeutic doses is through the kidneys either as salicylic acid or other biotransformation products. The renal clearance is greatly augmented by an alkaline urine as is produced by concurrent administration of sodium bicarbonate or potassium citrate.
The biotransformation of aspirin occurs primarily in the hepatocytes. The major metabolites are salicyluric acid (75%), the phenolic and acyl glucuronides of salicylate (15%), and gentisic and gentisuric acid (1%). The bioavailability of the aspirin component of butalbital 50 MG / aspirin 325 MG / caffeine 40 MG Oral Capsule, aspirin, and caffeine capsules is equivalent to that of a solution except for a slower rate of absorption. A peak concentration of 8.80 mcg/mL was obtained at 40 minutes after a 650 mg dose.
butalbital 50 MG / aspirin 325 MG / caffeine 40 MG Oral Capsule
butalbital 50 MG / aspirin 325 MG / caffeine 40 MG Oral Capsule is well absorbed from the gastrointestinal tract and is expected to distribute to most of the tissues in the body. Barbiturates, in general, may appear in breast milk and readily cross the placental barrier. They are bound to plasma and tissue proteins to a varying degree and binding increases directly as a function of lipid solubility.
Elimination of butalbital 50 MG / aspirin 325 MG / caffeine 40 MG Oral Capsule is primarily via the kidney (59% to 88% of the dose) as unchanged drug or metabolites. The plasma half-life is about 35 hours. Urinary excretion products included parent drug (about 3.6% of the dose), 5-isobutyl-5-(2,3-dihydroxypropyl) barbituric acid (about 24% of the dose), 5-allyl-5(3-hydroxy-2-methyl-1-propyl) barbituric acid (about 4.8% of the dose), products with the barbituric acid ring hydrolyzed with excretion of urea (about 14% of the dose), as well as unidentified materials. Of the material excreted in the urine, 32% was conjugated.
The bioavailability of the butalbital 50 MG / aspirin 325 MG / caffeine 40 MG Oral Capsule component of butalbital 50 MG / aspirin 325 MG / caffeine 40 MG Oral Capsule, aspirin, and caffeine capsules is equivalent to that of a solution except for a decrease in the rate of absorption. A peak concentration of 2,020 ng/mL is obtained at about 1.5 hours after a 100 mg dose. The in vitro plasma protein binding of butalbital 50 MG / aspirin 325 MG / caffeine 40 MG Oral Capsule is 45% over the concentration range of 0.5 to 20 mcg/mL.
This falls within the range of plasma protein binding (20% to 45%) reported with other barbiturates such as phenobarbital, pentobarbital, and secobarbital sodium. The plasma-to-blood concentration ratio was almost unity indicating that there is no preferential distribution of butalbital 50 MG / aspirin 325 MG / caffeine 40 MG Oral Capsule into either plasma or blood cells.
Caffeine
Like most xanthines, caffeine is rapidly absorbed and distributed in all body tissues and fluids, including the CNS, fetal tissues, and breast milk.
Caffeine is cleared rapidly through metabolism and excretion in the urine. The plasma half-life is about 3.0 hours. Hepatic biotransformation prior to excretion results in about equal amounts of 1-methylxanthine and 1-methyluric acid. Of the 70% of the dose that has been recovered in the urine, only 3% was unchanged drug.
The bioavailability of the caffeine component for butalbital 50 MG / aspirin 325 MG / caffeine 40 MG Oral Capsule, aspirin, and caffeine capsules is equivalent to that of a solution except for a slightly longer time to peak. A peak concentration of 1,660 ng/mL was obtained in less than an hour for an 80 mg dose.
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INDICATIONS AND USAGE

butalbital 50 MG / aspirin 325 MG / caffeine 40 MG Oral Capsule, aspirin, and caffeine capsules are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of butalbital 50 MG / aspirin 325 MG / caffeine 40 MG Oral Capsule, aspirin, and caffeine capsules in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital 50 MG / aspirin 325 MG / caffeine 40 MG Oral Capsule is habit-forming and potentially abusable.

CONTRAINDICATIONS

butalbital 50 MG / aspirin 325 MG / caffeine 40 MG Oral Capsule, aspirin, and caffeine capsules are contraindicated under the following conditions:

WARNINGS

Therapeutic doses of aspirin can cause anaphylactic shock and other severe allergic reactions. It should be ascertained if the patient is allergic to aspirin, although a specific history of allergy may be lacking.
Significant bleeding can result from aspirin therapy in patients with peptic ulcer or other gastrointestinal lesions, and in patients with bleeding disorders. Aspirin administered preoperatively may prolong the bleeding time. butalbital 50 MG / aspirin 325 MG / caffeine 40 MG Oral Capsule is habit-forming and potentially abusable. Consequently, the extended use of butalbital 50 MG / aspirin 325 MG / caffeine 40 MG Oral Capsule, aspirin, and caffeine capsules is not recommended. Results from epidemiologic studies indicate an association between aspirin and Reye's Syndrome. Caution should be used in administering this product to children, including teenagers, with chicken pox or flu.
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PRECAUTIONS

General

butalbital 50 MG / aspirin 325 MG / caffeine 40 MG Oral Capsule, aspirin, and caffeine capsules should be prescribed with caution for certain special-risk patients such as the elderly or debilitated, and those with severe impairment of renal or hepatic function, coagulation disorders, head injuries, elevated intracranial pressure, acute abdominal conditions, hypothyroidism, urethral stricture, Addison's disease, or prostatic hypertrophy.
Aspirin should be used with caution in patients on anticoagulant therapy and in patients with underlying hemostatic defects, and extreme caution in the presence of peptic ulcer.
Precautions should be taken when administering salicylates to persons with known allergies. Hypersensitivity to aspirin is particularly likely in patients with nasal polyps, and relatively common in those with asthma.

Information for Patients

Patients should be informed that butalbital 50 MG / aspirin 325 MG / caffeine 40 MG Oral Capsule, aspirin, and caffeine capsules contain aspirin and should not be taken by patients with an aspirin allergy.
butalbital 50 MG / aspirin 325 MG / caffeine 40 MG Oral Capsule, aspirin, and caffeine capsules may impair the mental and/or physical abilities required for performance of potentially hazardous tasks such as driving a car or operating machinery. Such tasks should be avoided while taking butalbital 50 MG / aspirin 325 MG / caffeine 40 MG Oral Capsule, aspirin, and caffeine capsules.
Alcohol and other CNS depressants may produce an additive CNS depression when taken with butalbital 50 MG / aspirin 325 MG / caffeine 40 MG Oral Capsule, aspirin, and caffeine capsules and should be avoided.
butalbital 50 MG / aspirin 325 MG / caffeine 40 MG Oral Capsule may be habit-forming. Patients should take the drug only for as long as it is prescribed, in the amounts prescribed, and no more frequently than prescribed.

Laboratory Tests

In patients with severe hepatic or renal disease, effects of therapy should be monitored with serial liver and/or renal function tests.

Drug Interactions

The CNS effects of butalbital 50 MG / aspirin 325 MG / caffeine 40 MG Oral Capsule may be enhanced by monoamine oxidase inhibitors.
In patients receiving concomitant corticosteroids and chronic use of aspirin, withdrawal of corticosteroids may result in salicylism because corticosteroids enhance renal clearance of salicylates and their withdrawal is followed by return to normal rates of renal clearance.
butalbital 50 MG / aspirin 325 MG / caffeine 40 MG Oral Capsule, aspirin, and caffeine capsules may enhance the effects of:

butalbital 50 MG / aspirin 325 MG / caffeine 40 MG Oral Capsule, aspirin, and caffeine capsules may diminish the effects of:
Uricosuric agents such as probenecid and sulfinpyrazone, reducing their effectiveness in the treatment of gout. Aspirin competes with these agents for protein binding sites.

Drug/Laboratory Test Interactions

Aspirin: Aspirin may interfere with the following laboratory determinations in blood: serum amylase, fasting blood glucose, cholesterol, protein, serum glutamic-oxaloacetic transaminase (SGOT), uric acid, prothrombin time and bleeding time. Aspirin may interfere with the following laboratory determinations in urine: glucose, 5-hydroxyindoleacetic acid, Gerhardt ketone, vanillylmandelic acid (VMA), uric acid, diacetic acid, and spectrophotometric detection of barbiturates.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Adequate long-term studies have been conducted in mice and rats with aspirin, alone or in combination with other drugs, in which no evidence of carcinogenesis was seen. No adequate studies have been conducted in animals to determine whether aspirin has a potential for mutagenesis or impairment of fertility. No adequate studies have been conducted in animals to determine whether butalbital 50 MG / aspirin 325 MG / caffeine 40 MG Oral Capsule has a potential for carcinogenesis, mutagenesis, or impairment of fertility.

Usage in Pregnancy

Teratogenic Effects

Pregnancy Category C. Animal reproduction studies have not been conducted with butalbital 50 MG / aspirin 325 MG / caffeine 40 MG Oral Capsule, aspirin, and caffeine capsules. It is also not known whether butalbital 50 MG / aspirin 325 MG / caffeine 40 MG Oral Capsule, aspirin, and caffeine capsules can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. butalbital 50 MG / aspirin 325 MG / caffeine 40 MG Oral Capsule, aspirin, and caffeine capsules should be given to a pregnant woman only when clearly needed.

Nonteratogenic Effects

Withdrawal seizures were reported in a two-day-old male infant whose mother had taken a butalbital-containing drug during the last 2 months of pregnancy. butalbital 50 MG / aspirin 325 MG / caffeine 40 MG Oral Capsule was found in the infant's serum. The infant was given phenobarbital 5 mg/kg, which was tapered without further seizure or other withdrawal symptoms.
Studies of aspirin use in pregnant women have not shown that aspirin increases the risk of abnormalities when administered during the first trimester of pregnancy. In controlled studies involving 41,337 pregnant women and their offspring, there was no evidence that aspirin taken during pregnancy caused stillbirth, neonatal death or reduced birth weight. In controlled studies of 50,282 pregnant women and their offspring, aspirin administration in moderate and heavy doses during the first four lunar months of pregnancy showed no teratogenic effect.
Therapeutic doses of aspirin in pregnant women close to term may cause bleeding in mother, fetus, or neonate. During the last 6 months of pregnancy, regular use of aspirin in high doses may prolong pregnancy and delivery.

Labor and Delivery

Ingestion of aspirin prior to delivery may prolong delivery or lead to bleeding in the mother or neonate.

Nursing Mothers

Aspirin, caffeine, and barbiturates are excreted in breast milk in small amounts, but the significance of their effects on nursing infants is not known. Because of potential for serious adverse reactions in nursing infants from butalbital 50 MG / aspirin 325 MG / caffeine 40 MG Oral Capsule, aspirin, and caffeine capsules, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.
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ADVERSE REACTIONS

The most frequent adverse reactions are drowsiness and dizziness. Less frequent adverse reactions are lightheadedness and gastrointestinal disturbances including nausea, vomiting, and flatulence. A single incidence of bone marrow suppression has been reported with the use of butalbital 50 MG / aspirin 325 MG / caffeine 40 MG Oral Capsule, aspirin, and caffeine capsules. Several cases of dermatological reactions including toxic epidermal necrolysis and erythema multiforme have been reported.

DRUG ABUSE AND DEPENDENCE

Controlled Substance

butalbital 50 MG / aspirin 325 MG / caffeine 40 MG Oral Capsule, aspirin, and caffeine capsules are controlled by the Drug Enforcement Administration and are classified under Schedule III.

Abuse and Dependence

butalbital 50 MG / aspirin 325 MG / caffeine 40 MG Oral Capsule
Barbiturates may be habit-forming: Tolerance, psychological dependence, and physical dependence may occur especially following prolonged use of high doses of barbiturates. The average daily dose for the barbiturate addict is usually about 1,500 mg. As tolerance to barbiturates develops, the amount needed to maintain the same level of intoxication increases; tolerance to a fatal dosage, however, does not increase more than two-fold. As this occurs, the margin between an intoxication dosage and fatal dosage becomes smaller. The lethal dose of a barbiturate is far less if alcohol is also ingested. Major withdrawal symptoms (convulsions and delirium) may occur within 16 hours and last up to 5 days after abrupt cessation of these drugs. Intensity of withdrawal symptoms gradually declines over a period of approximately 15 days. Treatment of barbiturate dependence consists of cautious and gradual withdrawal of the drug. Barbiturate-dependent patients can be withdrawn by using a number of different withdrawal regimens. One method involves initiating treatment at the patient's regular dosage level and gradually decreasing the daily dosage as tolerated by the patient.
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OVERDOSAGE

The toxic effects of acute overdosage of butalbital 50 MG / aspirin 325 MG / caffeine 40 MG Oral Capsule, aspirin, and caffeine capsules are attributable mainly to its barbiturate component, and, to a lesser extent, aspirin. Because toxic effects of caffeine occur in very high dosages only, the possibility of significant caffeine toxicity from butalbital 50 MG / aspirin 325 MG / caffeine 40 MG Oral Capsule, aspirin, and caffeine capsules overdosage is unlikely.
Signs and Symptoms
Symptoms attributable to acute barbiturate poisoning include drowsiness, confusion, and coma; respiratory depression; hypotension; hypovolemic shock. Symptoms attributable to acute aspirin poisoning include hyperpnea; acid-base disturbances with development of metabolic acidosis; vomiting and abdominal pain; tinnitus; hyperthermia; hypoprothrombinemia; restlessness; delirium; convulsions. Acute caffeine poisoning may cause insomnia, restlessness, tremor, and delirium; tachycardia and extrasystoles.
Treatment
Treatment consists primarily of management of barbiturate intoxication and the correction of the acid-base imbalance due to salicylism. Vomiting should be induced mechanically or with emetics in the conscious patient. Gastric lavage may be used if the pharyngeal and laryngeal reflexes are present and if less than 4 hours have elapsed since ingestion. A cuffed endotracheal tube should be inserted before gastric lavage of the unconscious patient and when necessary to provide assisted respiration. Diuresis, alkalinization of the urine, and correction of electrolyte disturbances should be accomplished through administration of intravenous fluids such as 1% sodium bicarbonate in 5% dextrose in water. Meticulous attention should be given to maintaining adequate pulmonary ventilation. The value of vasopressor agents such as Norepinephrine or Phenylephrine Hydrochloride in treating hypotension is questionable since they increase vasoconstriction and decrease blood flow. However, if prolonged support of blood pressure is required, Norepinephrine Bitartrate (Levophed®) Levophed is a registered Trademark of Sanofi Winthrop Pharmaceuticals. may be given I.V. with the usual precautions and serial blood pressure monitoring. In severe cases of intoxication, peritoneal dialysis, hemodialysis, or exchange transfusion may be lifesaving. Hypoprothrombinemia should be treated with Vitamin K, intravenously.
Up-to-date information about the treatment of overdose can often be obtained from a Certified Regional Poison Control Center. Telephone numbers of Certified Regional Poison Control Centers are listed in the Physicians' Desk Reference® Trademark of Medical Economics Company, Inc. .
Toxic and Lethal Doses (for adults)
butalbital 50 MG / aspirin 325 MG / caffeine 40 MG Oral Capsule: toxic dose 1 g (20 capsules of butalbital 50 MG / aspirin 325 MG / caffeine 40 MG Oral Capsule, aspirin, and caffeine)
Aspirin: toxic blood level greater than 30 mg/100 mL; lethal dose 10 to 30 g
Caffeine: toxic dose 1 g (25 capsules of butalbital 50 MG / aspirin 325 MG / caffeine 40 MG Oral Capsule, aspirin, and caffeine)
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DOSAGE AND ADMINISTRATION

One or 2 capsules every 4 hours. Total daily dose should not exceed 6 capsules. Extended and repeated use of this product is not recommended because of the potential for physical dependence.

HOW SUPPLIED

butalbital 50 MG / aspirin 325 MG / caffeine 40 MG Oral Capsule, aspirin, and caffeine capsules are dark green and light green in color, imprinted with logo "LANNETT" on the cap and "1552" on the body. Each capsule contains: butalbital 50 MG / aspirin 325 MG / caffeine 40 MG Oral Capsule USP, 50 mg; aspirin USP, 325 mg; caffeine USP, 40 mg and is available as follows:
Bottles of 100 NDC 0527-1552-01
Dispense in a tight container as defined in the USP. Use child-resistant closure. Store at 20° to 25°C (68° to 77°F) .
Protect from moisture.
Distributed by:
Lannett Company, Inc.
Philadelphia, PA 19154
Made in the USA
CIB70308C
Rev. 04/17

Select the most affordable brand or generic drug


StrengthQuantityPrice, USDCountry
0 30 $57.95USA
0 100 $115.90USA
50 /325/40mg30 $36.95USA
50 /325/40mg100 $73.90USA
50 /325/40mg100 $138.00

References

  1. Dailymed."Caffeine; ergotamine tartrate: dailymed provides trustworthy information about marketed drugs in the united states. dailymed is the official provider of fda label information (package inserts).". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. Dailymed."Aspirin; butalbital; caffeine; codeine phosphate: dailymed provides trustworthy information about marketed drugs in the united states. dailymed is the official provider of fda label information (package inserts).". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  3. Dailymed."Aspirin; dipyridamole: dailymed provides trustworthy information about marketed drugs in the united states. dailymed is the official provider of fda label information (package inserts).". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).

Butalbital 50 MG / aspirin 325 MG / caffeine 40 MG Oral Capsule - Frequently asked Questions

Can Butalbital 50 MG / aspirin 325 MG / caffeine 40 MG Oral Capsule be stopped immediately or do I have to stop the consumption gradually to ween off?

In some cases, it always advisable to stop the intake of some medicines gradually because of the rebound effect of the medicine.

It's wise to get in touch with your doctor as a professional advice is needed in this case regarding your health, medications and further recommendation to give you a stable health condition.

Can Butalbital 50 MG / aspirin 325 MG / caffeine 40 MG Oral Capsule be taken or consumed while pregnant?

Please visit your doctor for a recommendation as such case requires special attention.

Can Butalbital 50 MG / aspirin 325 MG / caffeine 40 MG Oral Capsule be taken for nursing mothers or during breastfeeding?

Kindly explain your state and condition to your doctor and seek medical advice from an expert.

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Following the study conducted by gmedication.com on Butalbital 50 MG / aspirin 325 MG / caffeine 40 MG Oral Capsule, the result is highlighted below. However, it must be clearly stated that the survey and result is based solely on the perception and impression of visitors and users of the website as well as consumers of Butalbital 50 MG / aspirin 325 MG / caffeine 40 MG Oral Capsule. We, therefore, urge readers not to base their medical judgment strictly on the result of this study but on test/diagnosis duly conducted by a certified medical practitioners or physician.

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The information was verified by Dr. Vishal Pawar, MD Pharmacology